Zdrowie i gospodarka · 25/09/2019

FDA Proposes Rule for Premarket Tobacco Product Applications and Recordkeeping Requirements

The US Food and Drug Administration (FDA) is issuing a proposed rule that outlines requirements for tobacco product manufacturers to submit premarket tobacco product applications (PMTAs) and maintain records to demonstrate the safety of their products, in order to ensure that PMTAs contain sufficient information for the FDA to determine whether a marketing order should be issued for a new tobacco product.